Handbook of Adaptive Designs in Pharmaceutical and Clinical Development

ISBN-13: 9780367577117 / Angielski / Miękka / 2020 / 496 str.

Annpey Pong; Shein-Chung Chow

Opis

This handbook provides a comprehensive and unified presentation of the principles and latest statistical methodologies used when modifying trial procedures based on accrued data of ongoing clinical trials. The book also gives a well-balanced summary of current regulatory perspectives and presents real-world examples of a range of adaptive design

Spis treści

Overview of Adaptive Design Methods in Clinical Trials. Fundamental Theory of Adaptive Designs with Unplanned Design Change in Clinical Trials with Blinded Data. Bayesian Approach for Adaptive Design. The Impact of Protocol Amendments in Adaptive Trial Designs. From Group Sequential to Adaptive Designs. Determining Sample Size for Classical Designs. Sample Size Reestimation Design with Applications in Clinical Trials. Adaptive Interim Analyses in Clinical Trials. Classical Dose-Finding Trial. Improving Dose-Finding: A Philosophic View. Adaptive Dose-Ranging Studies. Seamless Phase I/II Designs. Phase II/III Seamless Designs. Sample Size Estimation/Allocation for Two-Stage Seamless Adaptive Trial Designs. Optimal Response-Adaptive Randomization for Clinical Trials. Hypothesis-Adaptive Design. Treatment Adaptive Allocations in Randomized Clinical Trials: An Overview. Integration of Predictive Biomarker Diagnostics into Clinical Trials for New Drug Development. Clinical Strategy for Study Endpoint Selection. Adaptive Infrastructure. Independent Data Monitoring Committees. Targeted Clinical Trials. Functional Genome-Wide Association Studies of Longitudinal Traits. Adaptive Trial Simulation. Efficiency of Adaptive Designs. Cases Studies in Adaptive Design. Good Practices for Adaptive Clinical Trials. Index.

O autorze

Annpey Pong is a manager in the Department of Biostatistics and Research Decision Sciences at Merck Research Laboratories. Dr. Pong is also the associate editor of the Journal of Biopharmaceutical Statistics. She earned her Ph.D. in statistics from Temple University.

Shein-Chung Chow is a professor in the Department of Biostatistics and Bioinformatics at Duke University School of Medicine. Dr. Chow is also a professor of clinical sciences at Duke–National University of Singapore Graduate Medical School and the editor of the Journal of Biopharmaceutical Statistics. He earned his Ph.D. in statistics from the University of Wisconsin–Madison.